|
Device |
electrocardiograph |
Product Code | DPS |
Regulation Number |
870.2340
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACCURKARDIA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACME PORTABLE MACHINES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADVANCED INSTRUMENTATIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALIVECOR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
AMCG CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANDON HEALTH CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANYBATTERY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
B-SECUR LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMAGNETIK-PARK GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIONET CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
BONUS COMMUNICACIONES SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BRENTWOOD MEDICAL TECHNOLOGY CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BSP-BIIOLOGICAL SIGNAL PROCESSING, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAF MEDICAL SOLUTIONS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAIRD TECHNOLOGY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDEA ASSOCIATES INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIAC SCIENCE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIACSENSE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CARDIO COMM SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CARDIO-PHOENIX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CARDIOCOMM SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIOLINE S.P.A |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CARDIOLOGS TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
COALA LIFE AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COMMWELL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONTEC MEDICAL SYSTEM CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CONTEC MEDICAL SYSTEMS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONTEC MEDICAL SYSTEMS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONTEC MEDICAL SYSTEMS CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORSCIENCE GMBH & CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CREAVO MEDICAL TECHNOLOGIES, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DAILYCARE BIOMEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIMETEK DIGITAL MEDICAL TECHNOLOGIES LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DYANSYS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DYNACARDIA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDAN INSTRUMENTS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDAN INSTRUMENTS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDAN INSTRUMENTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
16
|
EKGENIUS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ET MEDICAL DEVICES SPA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUKUDA DENSHI USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYST. INFORMATION TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS CHINA CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GEM-MED S.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GENETESIS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HARBINGER MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HHSSYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMEDRIX INC. (FORMERLY PIITECH INC.) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INVISIONHEART INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MASIMO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MDOLORIS MEDICAL SYSTEMS SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIBLU MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICAL POSITIONING, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICAL PREDICTIVE SCIENCE CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICAL PREDICTIVE SCIENCE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICALGORITHMICS S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIZIN SYSTEME BOBLINGEN GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEMTEC CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIDIAN DYNAMICS BIOMEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MESI, DEVELOPMENT OF MEDICAL DEVICES, LTD; MESI, D.O.O. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MITAC INTERNATIONAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MOBHEALTH INCORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MORTARA INSTRUMENT, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MORTARA INSTRUMENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
PHILIPS HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
PHYSIQ INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHYSIQ, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PULSE BIOMEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REKA PTE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAMSUNG STRATEGY AND INNOVATION CENTER (SSIC) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCHILLER AG |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SHENZHEN BIOCARE ELECTRONICS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SHENZHEN CAREWELL ELECTRONICS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN CAREWELL ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN LE MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SONOSCAPE COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPACELABS HEALTHCARE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPAULDING CLINICAL RESEARCH, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SUZUKEN CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAIDOC TECHNOLOGY CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRISMED CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRISTAN TECHNOLOGIES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VALES & HILLS BIOMEDICAL TECH. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VECTRACOR, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VECTRACOR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VICOR TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WELCH ALLYN |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WELCH ALLYN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WIPRO GE HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WITHINGS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WITHINGS SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZOLL MANUFACTURING CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZYWIE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Baxter Healthcare Corporation |
II |
Jul-10-2024 |
2 |
Baxter Healthcare Corporation |
II |
Jan-10-2024 |
3 |
Baxter Healthcare Corporation |
II |
Jan-24-2023 |
4 |
Del Mar Reynolds Medical, Ltd. |
II |
Jan-13-2012 |
5 |
Edan Instruments, Inc. |
II |
Oct-12-2011 |
6 |
GE Healthcare, LLC |
II |
Dec-07-2020 |
7 |
GE Medical Systems, LLC |
II |
Jan-21-2010 |
8 |
Mortara Instrument, Inc |
II |
Jun-12-2015 |
9 |
Philips Healthcare Inc. |
II |
Jun-17-2011 |
10 |
Philips North America, LLC |
II |
Jun-10-2020 |
11 |
Philips North America, LLC |
II |
Feb-21-2019 |
12 |
Schiller, Ag |
II |
Aug-27-2024 |
13 |
WELCH ALLYN, INC/MORTARA |
II |
Dec-09-2020 |
14 |
WELCH ALLYN, INC/MORTARA |
II |
Apr-29-2020 |
15 |
Welch Allyn Inc Mortara |
II |
Oct-02-2021 |
16 |
Welch Allyn Inc Mortara |
II |
Apr-22-2021 |
17 |
Withings |
II |
Mar-22-2023 |
|
|
|
|